The United States filed a civil complaint against Riddhi USA Inc. of Ronkonkoma, New York, and its owner and President Mohd M. Alam to prevent the distribution of adulterated and misbranded dietary supplements in violation of federal law, the Department of Justice announced today.
The complaint alleges that Riddhi USA Inc. (Riddhi) and Mr. Alam engage in manufacturing, preparing, labeling, packing, repacking, holding, and distributing dietary supplements and are contract manufacturers of dietary supplements distributed under other companies' names. The complaint, filed in the U.S. District Court for the Eastern District of New York, alleges that dietary supplements that defendants manufactured, prepared, packed, repacked, labeled, held and distributed were adulterated and misbranded. The complaint further alleges that these dietary supplements were prepared, packed, and held under conditions that do not comply with current good manufacturing practice regulations for these types of products.
The Department filed the complaint at the request of the U.S. Food and Drug Administration (FDA).
"The Department of Justice is committed to ensuring that dietary supplement manufacturers comply with laws designed to protect consumers," said Acting Assistant Attorney General Chad A. Readler, head of the Justice Department's Civil Division. "The Department of Justice will continue to work with the FDA to protect the public from adulterated and misbranded products, and to ensure that dietary supplement manufacturers provide accurate information about what is in their products."
"Dietary supplement manufacturers that do not comply with applicable laws and regulations designed to protect consumers put those consumers at risk," said Acting U.S. Attorney Bridget M. Rohde of the Eastern District of New York. "Today's action demonstrates the Department's commitment to safeguarding the public from adulterated and misbranded products."
According to the complaint, FDA inspected the defendants' facility in January 2017 and found numerous significant deviations from current good manufacturing practice regulations. For example, as alleged in the complaint, defendants failed to establish product specifications for identity, purity, strength, and composition of their finished dietary supplements, failed to conduct at least one appropriate test to verify the identity of a dietary ingredient, and failed to establish and follow written procedures for quality control operations.
The complaint further alleges that many of the current good manufacturing practice deviations observed during FDA's January 2017 inspection were the same or similar to those observed by FDA during a previous inspection of defendants' facility that occurred in January 2016. The complaint noted that following the January 2016 inspection, FDA issued a warning letter to defendants detailing violations of current good manufacturing practice regulations observed during the 2016 inspection. The complaint alleges that the current good manufacturing practice violations noted in the warning letter were the same as or similar to those observed during FDA's subsequent 2017 inspection.
The complaint also alleges that the defendants misbranded their dietary supplements by failing to comply with the relevant labeling provisions of the federal Food, Drug, and Cosmetic Act. For example, as noted in the complaint, defendants' products are fabricated from two or more ingredients but fail to declare any ingredients on their product labels or labeling. Food, including dietary supplements, is also misbranded if its label or labeling fails to declare the major food allergen "soy" as defined in the law. The complaint alleges that defendants' Neuroxygen dietary supplement product is misbranded because it is manufactured using soy lecithin, which contains "soy," but defendants fail to list soy on the product label. In addition, the complaint alleges that some of the defendants' products, including Prenatal Formula, Osteo Gest, Neuroxygen, Inflam-Ease, and All-Ease, are misbranded in that the products' label or labeling fail to declare the place of business of the manufacturer, packer, or distributor.
The government is represented by Trial Attorney Monica Groat of the Civil Division's Consumer Protection Branch and Assistant U.S. Attorney Edwin Cortes of the U.S. Attorney's Office for the Eastern District of New York, with the assistance of Associate Chief Counsel for Enforcement Roselle Oberstein of the FDA, Office of General Counsel, Department of Health and Human Services.
A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.